Z-2375-2012Class II

Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm Ref: KC-54060. The Apex Knee System is...

Name: Z-2375-2012 Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm Ref: KC-54060. The Apex Knee System is...
Creator: Omni Life Science
Published: 2012-08-09
License: https://open.fda.gov/license/

Omni Life Science, Inc. / initiated 2012-08-09 / Terminated / root cause: packaging

FDA source

Omni Life Science began a recall of Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm Ref: KC-54060. The Apex Knee System is intended for use as a primary or revision total... on 2012-08-09. FDA classified it as Class II and gives the reason as "The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2375-2012
Classification: Class II
Status: Terminated
Initiated: 2012-08-09
Posted: 2012-09-13
Terminated: 2013-01-10
Recalling firm: Omni Life Science, Inc.
Product: Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm Ref: KC-54060. The Apex Knee System is intended for use as a primary or revision total knee replacement.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
Root cause tag: packaging
FDA root cause: Packaging
Action: Omnilife Science contacted affected customers by phone and sent an "URGENT MEDICAL DEVICE RECALL" e-mail on August 9, 2012. The e-mail identifies the product, problem, and actions to be taken by the customers. Customers with questions regarding product return should contact Customer Service at 800-448-6664. Customers with questions regarding the recall should contact the firm at 774-226-1845.
Quantity in commerce: 36 units
Distribution: Worldwide Distribution-USA (nationwide including the states of CO, NY, OK, PA, UT, VA, and WI, and the countries of Spain and the Netherlands.
Product codes and lots: Lot Numbers: 10723, 10763, 10824

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2375-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2370-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-19	2012-09-13
Z-2371-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-19	2012-09-13
Z-2372-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-19	2012-09-13
Z-2373-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-19	2012-09-13
Z-2374-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-19	2012-09-13
Z-2375-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-19	2012-09-13

Product code JWH

K094017Class IITibial Baseplate Augment Model Kc-22118, Kc-22128, Kc-22138, Kc-22148, Kc-22158Omni Life Science, Inc. / cleared 2010-03-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)